- The Process Controls Engineer is responsible for the planning, development, design and maintenance of control systems in the facility.
ESSENTIAL DUTIES / RESPONSIBILITIES: - Monitor and improve machine process, develop work instructions and train employees
- Participate in implementing safety improvements
- Design, program, analyze and repair electrical drives and control units
- Provide technical expertise in troubleshooting Programmable Electronic Systems
- Modify control system logic and industrial machinery to optimize equipment performance and control
- Investigate operational problems affecting production in a systematic and methodical manner
QUALIFICATIONS/EXPERIENCE: - Bachelor's degree (or above) in engineering, preferably electrical or controls engineering
- 5-7 years of controls engineering experience
- Experience in high-volume, high speed manufacturing
- Experience in pharmaceutical, medical device industry strongly preferred
- Hands on experience with packaging equipment, process and controls desired
- PLC experience (Allen Bradley, B&R, Siemens)
SPECIFIC SKILLS - Strong background in technical troubleshooting, problem solving.
- Detailed knowledge of equipment operation and validation requirements.
- Proficient knowledge of pharmaceutical cGMP requirements and systems.
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
- This position requires the ability to think in high level terms to develop technical solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes.
- Ability to foster and maintain an environment of proactive working practices, and effective communication within the group, and between the group and external functions.
- Strong problem solving and investigation techniques.
- Excellent written and oral communication skills.
- Demonstrated performance in project management.
- Strong organization skills with the ability to multi-task in a dynamic environment and balance multiple priorities.
- Expertise with solid and liquid pharmaceutical manufacturing processes, equipment, and operations.
- Must be capable of working independently, with self-initiative, self-motivation, and self-strategic direction, while also effectively working within team and matrix environment to influence and guide activity.
- Proven ability to work on complex problems and interpret scientific data where analysis requires an evaluation of intangible variables.
- Solid understanding and interpretation of Regulatory guidance documents and filing mechanisms.
- Experience preparing and delivering technical presentations.
- Ability to interact with people at all levels of the organization as well as some interaction with government agencies.
Computer Skills: - Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
- Basic Word for Windows skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files.
- Intermediate Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts.
- Intermediate Microsoft Project skills as evidenced by the ability to assign resources and their work schedules to tasks, effectively use the different views, reports, and drawing tools, resolve time and resource conflicts, sort and filter information effectively and work with subtasks in an outline form, link tasks effectively and work with time constraints, create a baseline plan and track an active project, customize Project and work with data in other applications, manage tasks that will occur in the future and work with resource needs.
PHYSICAL REQUIREMENTS/ENVIRONMENT - Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
- Must be able to work on a computer for extended periods of time.
- Must wear safety glasses and other protective items as required.
- Must demonstrate visual acuity, color recognition, finger dexterity.
- The ability to read, write and communicate in English.
- Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.
- Sitting approximately 50% of day and standing approximately 50% of day.
- Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.
- Occasional lifting of up to 35 pounds.
- Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
- Occasionally subjected to weekend, holiday and irregular hours.
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